Aspirin 81mg Enteric Coated

Product NDC
77333-031
11-digit product format
773330031
Labeler code
77333
Product ID
77333-031_5d297e80-59c6-fb69-e063-6394a90ab9e0
Type
HUMAN OTC DRUG
Nonproprietary name
Aspirin
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Gendose Pharmaceuticals, LLC
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-05-01
Substance
ASPIRIN
Active strength
81 mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Aspirin 81mg Enteric Coated
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ASPIRIN81 mg/1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657Product name120150929
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94eProduct name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77333-031-20Aspirin 81mg Enteric Coated150 in 1 CARTONTABLET, DELAYED RELEASE1501
77333-031-25Aspirin 81mg Enteric Coated1 in 1 BLISTER PACKTABLET, DELAYED RELEASE11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
77333-031-20EA - Each77333-03185eb169d-e2f9-45af-8243-e5450ed3cde812025-05-14
77333-031-25EA - Each77333-031f4575ebe-fdd0-4355-b91e-7fd0193f093a12025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77333-031ASPIRIN 81MG ENTERIC COATED (ASPIRIN) TABLET, DELAYED RELEASE [GENDOSE PHARMACEUTICALS, LLC]1Current NDC, 2 package rows20250501_7342bbf4-ebb9-446d-83bb-6ddcb3a44fa7.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 38 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TYLENOL Extra StrengthACETAMINOPHENKenvue Brands LLCab02080a-c903-4e4a-a9f3-2b8197ed2f2b2025-09-17WarningsExact identifier
application number: M013
Childrens TYLENOLACETAMINOPHENKenvue Brands LLC79669930-f744-4bb1-8325-b75951489b642025-09-17WarningsExact identifier
application number: M013
Pain Reliever PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLL.N.K. International, Inc.ff199db8-c7ea-4b6e-ad8b-3ceeca883d922025-09-15WarningsExact identifier
application number: M013
Acetaminophen PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLFOODHOLD U.S.A., LLCfdd7ce80-d6be-41b9-affd-d024cf306b502025-09-12WarningsExact identifier
application number: M013
Extra Strength Pain RelieverACETAMINOPHENINGLES MARKETS, INC.3e89240b-0e27-fde4-e063-6394a90a779f2025-09-11WarningsExact identifier
application number: M013
Aspirin 81 mg Low DoseASPIRINHEB926fe7b6-9607-469f-912f-4019891067a92025-09-10WarningsExact identifier
application number: M013
Bayer Genuine AspirinASPIRINUnifirst First Aid Corporation356e4ff4-a7f1-4a50-9b86-2555e232b3002025-09-09WarningsExact identifier
application number: M013
Medique at Home AspirinASPIRINUnifirst First Aid Corporationb5a469c1-9ab4-5bd7-e053-2995a90a86d12025-09-09WarningsExact identifier
application number: M013
Medique Products AspirinASPIRINUnifirst First Aid Corporation9b28fed0-a993-ca72-e053-2995a90ac7fd2025-09-09WarningsExact identifier
application number: M013
Unishield AspirinASPIRINUnishieldba106b20-32ac-df90-e053-2995a90adaef2025-09-09WarningsExact identifier
application number: M013
Medi First Pain AcheASPIRIN,CAFFEINEUnifirst First Aid Corporatione82d02d5-3e44-a8f8-e053-2a95a90a26882025-09-09WarningsExact identifier
application number: M013
Medique at Home Back Pain ReliefMAGNESIUM SALICYLATEUnifirst First Aid Corporatione56c4aef-fa0b-74db-e053-2a95a90a97452025-09-09WarningsExact identifier
application number: M013
Travel Savvy AspirinASPIRINBellegrove Medical Supply, Inc.bae80044-ad7f-3bf5-e053-2995a90a42f92025-09-09WarningsExact identifier
application number: M013
McKesson AspirinASPIRINMcKesson Medical-Surgicaldabd741e-e11c-52c1-e053-2a95a90a91d52025-09-09WarningsExact identifier
application number: M013
Travel Savvy Non-AspirinACETAMINOPHEN 325MGBellegrove Medical Supply, Inc.6ab08633-5d5a-42b2-e053-2991aa0ab41a2025-09-09WarningsExact identifier
application number: M013
Direct Safety Aspirin FreeACETAMINOPHENConney Safety Products, LLC1c7369ea-46b6-407c-aa4b-048eb72ff03f2025-09-09WarningsExact identifier
application number: M013
Direct Safety Extra Strength Aspirin FreeACETAMINOPHENConney Safety Products, LLCa524c36a-38f3-4266-8f45-589e194003282025-09-09WarningsExact identifier
application number: M013
Direct Safety AspirinASPIRINDirect Safetyba9ba697-d3df-49d7-e053-2a95a90af4062025-09-09WarningsExact identifier
application number: M013
McKesson Acetaminophen 325ACETAMINOPHENMcKesson Medical-Surgical, Inc.bc2daba5-ce8b-bbda-e053-2a95a90a6f332025-09-09WarningsExact identifier
application number: M013
Uline Acetaminophen Extra StrengthACETAMINOPHENUline90167594-0a49-2492-e053-2a95a90a14012025-09-09WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308416aspirin 81 MG Delayed Release Oral TabletPSN7342bbf4-ebb9-446d-83bb-6ddcb3a44fa71
308416aspirin 81 MG Delayed Release Oral TabletSCD7342bbf4-ebb9-446d-83bb-6ddcb3a44fa71
308416ASA 81 MG Delayed Release Oral TabletSY7342bbf4-ebb9-446d-83bb-6ddcb3a44fa71
308416aspirin 81 MG Enteric Coated Oral TabletSY7342bbf4-ebb9-446d-83bb-6ddcb3a44fa71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
77333-031-2077333003120150 BLISTER PACK in 1 CARTON (77333-031-20) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK (77333-031-25) 150 blister pack2025-05-01NoNoCurrent
77333-031-25773330031251 in 1 BLISTER PACKHistorical